Global Quality Systems Lead — Strategy & Compliance

Initial Therapeutics, Inc.; Indianapolis (IN); Hybrid; USD 65,000 - 169,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Pension

Job summary

Lilly is seeking a Sr Principal (R4+) Global Quality Systems Lead to oversee and align QMS processes across the organization, supporting commercial and Clinical Supply functions. The role emphasizes governance, strategy, and continuous quality improvements within the Global Process Ownership framework.

Based in Indianapolis with some travel and a hybrid work arrangement, the position requires strong cGMP knowledge and collaboration with multiple functions to ensure compliance and quality across

Qualifications

• Bachelor's degree or equivalent in a scientific field, engineering, or a related discipline.
• Minimum of 7 years of direct cGMP experience, with strong knowledge of cGMP requirements and quality systems.
• Experience in at least one relevant area or modality, such as Quality Control laboratories, cell and gene therapy, or parenteral manufacturing.
• Fluent in English; additional languages are preferred.
• Previous experience with Quality Risk Management and global quality system governance.

Responsibilities

• Provide oversight and consulting support to Global Process Owners, Communities of Practice, Area Process Owners, and network areas for the interpretation, implementation, review, and approval of global quality system processes and documents.
• Lead and continuously improve governance, management review, process monitoring, and prioritization across the Operational Controls pillar to support timely decisions, consistent execution, and QMS health.
• Assess, develop, and implement global quality system improvements, including standards, practices, training, implementation tools, effectiveness measures, and performance insights aligned with regulatory, industry, and company expectations.
• Partner across manufacturing, external supplier organizations, marketing affiliate quality operations, research and development, Clinical Supply, and other enterprise functions to manage process risks, strengthen capability, and enable standardized global business processes.
• Monitor regulatory and industry developments, support inspection readiness, and engage with external organizations to help maintain compliance and influence quality-related policies and requirements.

Skills

cGMP experience

Quality governance

GxP understanding

Lean/CI

Education

Bachelor's degree in science/engineering

Job description

Lilly is seeking a Sr Principal (R4+) Global Quality Systems Lead to oversee and align QMS processes across the organization, supporting commercial and Clinical Supply functions. The role emphasizes governance, strategy, and continuous quality improvements within the Global Process Ownership framework.

Based in Indianapolis with some travel and a hybrid work arrangement, the position requires strong cGMP knowledge and collaboration with multiple functions to ensure compliance and quality across